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Objective: Datasets regarding patients with abdominal aortic aneurysm (AAA) have almost universally been restricted to single geographic regions. We aimed to obtain data on the risk factor profile and cardiovascular (CV) co-morbidity among multi-ethnic patients with known AAA in the global REACH (REduction of Atherothrombosis for Continued Health) Registry. Methods: The REACH Registry is an international, prospective, observational out-patient registry enrolling out-patients ≥45 years of age with established coronary artery disease (CAD), cerebrovascular disease (CVD) or peripheral arterial disease (PAD) or with at least three atherothrombotic risk factors. This report includes observations pertaining to 68,236 out-patients enrolled in 44 countries. Main outcome measures: Gender, ethnic origin, CV risk factors, established atherosclerotic disease (CAD, CVD and PAD) at baseline, and CV outcome events at 1-year were compared in patients with and without AAA. Results: An AAA was reported in 1722 (2.5%) of 68,236 out-patients enrolled in the REACH Registry. Older age (73 ± 8 vs 68 ± 10, P < .0001), male gender (81% vs 63%, P < .0001), White ethnicity (79% vs 67%, P < .0001) and a history of smoking (81% vs 55%, P < .0001) were independently related to the diagnosis of AAA. There was a weaker association with hypertension or hypercholesterolemia, and an inverse relation with diabetes. Fatal and non-fatal coronary and cerebrovascular event rates were not different between the AAA and non-AAA cohorts, but individuals with AAA suffered increased rates of other cardiovascular deaths (1.39% vs 0.94%, P = .0135), hospitalizations for atherothrombotic events (14.1% vs 9.3%, P < .0001) due to increased rates of revascularization procedures, and new or worsening PAD (3.7% vs 1.3%, P < .0001) at 1-year follow-up. Conclusion: This study, the largest published to date, presents the CV risk profile and outcome of patients with an established diagnosis of AAA from a cohort of patients with either overt manifestations of CV disease or multiple risk factors, and further defines these patients in a multi-ethnic, global context. [Copyright &y& Elsevier]

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A1c values. [Copyright &y& Elsevier]

Background Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease (PAD) and is the major cause of ischemic amputation in the United States. Risk factors and the associated incidence and prevalence of CLI have not been well described in the general population. This study describes the risk factors for PAD progression to CLI and estimates the annual incidence and prevalence of CLI in a representative United States patient cohort. Methods This was a retrospective cohort analysis of adults with commercial, Medicare supplemental, or Medicaid health insurance who had at least one PAD or CLI health care claim from January 1, 2003, through December 31, 2008, and 12 months of continuous coverage. Two subgroups of CLI presentation were identified: primary CLI (patients without any prior PAD or subsequent PAD diagnostic code >30 days after CLI diagnostic code) and secondary CLI (patients with prior PAD or subsequent PAD diagnostic codes ≤30 days of a CLI diagnostic code). Patterns of presentation, annual incidence, and prevalence of CLI were stratified by health care plan. Risk factors for progression to CLI were compared by presentation type. Results From 2003 to 2008, the mean annual incidence of PAD was 2.35% (95% confidence interval [CI], 2.34%-2.36%) and the incidence of CLI was 0.35% (95% CI, 0.34%-0.35%) of the eligible study population, with primary and secondary presentations occurring at similar rates. The mean annualized prevalence of PAD was 10.69% (95% CI, 10.67%10.70%) and the mean annualized prevalence of CLI was 1.33% (95% CI, 1.32%-1.34%) of the eligible study population, and two-thirds of the cases presented as secondary CLI. CLI developed in 11.08% (95% CI, 11.30%-11.13%) of patients with PAD. A multivariable model demonstrated that diabetes, heart failure, stroke, and renal failure were stronger predictors of primary rather than secondary CLI presentation. Conclusions These data establish new national estimates of the incidence and prevalence of CLI and define key risk factors that contribute to primary or secondary presentations of CLI within a very large contemporary insured population cohort in the United States. [ABSTRACT FROM AUTHOR]

Objective: The risk of acute type B aortic dissection is thought to increase with descending thoracic aortic diameter. Currently, elective repair of the descending thoracic aorta is indicated for an aortic diameter of 5.5 cm or greater. We sought to investigate the relationship between aortic diameter and acute type B aortic dissection, and the utility of aortic diameter as a predictor of acute type B aortic dissection. Methods: We examined the descending aortic diameter at presentation of 613 patients with acute type B aortic dissection who were enrolled in the International Registry of Acute Aortic Dissection between 1996 and 2009, and analyzed the subset of patients with acute type B aortic dissection with an aortic diameter less than 5.5 cm. Results: The median aortic diameter at the level of acute type B aortic dissection was 4.1 cm (range 2.1–13.0 cm). Only 18.4% of patients with acute type B aortic dissection in the International Registry of Acute Aortic Dissection had an aortic diameter of 5.5 cm or greater. Patients with Marfan syndrome represented 4.3% and had a slightly larger aortic diameter than patients without Marfan syndrome (4.68 vs 4.32 cm, P = .121). Complicated acute type B aortic dissection was more common among patients with an aortic diameter of 5.5 cm or greater (52.2% vs 35.6%, P < .001), and the in-hospital mortality for patients with an aortic diameter less than 5.5 cm and 5.5 cm or greater was 6.6% and 23.0% (P < .001), respectively. Conclusions: The majority of patients with acute type B aortic dissection present with a descending aortic diameter less than 5.5 cm before dissection and are not within the guidelines for elective descending thoracic aortic repair. Aortic diameter measurements do not seem to be a useful parameter to prevent aortic dissection, and other methods are needed to identify patients at risk for acute type B aortic dissection. [ABSTRACT FROM AUTHOR]

The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012. [Copyright &y& Elsevier]

Objectives: The purpose of this study is to determine if an ankle-brachial index (ABI) ≥1.40 is associated with reduced quality of life (QoL). Background: Ankle-brachial index values ≥1.40 have been associated with some cardiovascular disease (CVD) risk factors and increased mortality, but the relationship to other disease morbidity such as reduced QoL has not been previously evaluated. Methods: The PARTNERS (PAD Awareness, Risk and Treatment: New Resources for Survival) program was a national cross-sectional study of 7,155 patients age >50 years recruited from 350 primary care sites. All sites performed the ABI using a Doppler device and a standardized technique. Results: A total of 296 subjects had an ABI ≥1.40 in at least 1 leg, and 4,420 had an ABI between 0.90 and 1.40. Diabetes, male gender, and waist circumference were positively associated with a high ABI, and smoking and dyslipidemia were inversely associated with a high ABI. After adjustment for age, gender, and the traditional CVD risk factors, and accounting for multiple comparisons, the high ABI group had significantly higher odds for foot ulcers (p < 0.005) and borderline associations with heart failure, stroke, and neuropathy. After the same adjustments and adjusting for patients with other CVD, the high ABI group scored 2.0 points lower on the physical component scale on the Medical Outcomes Study Standard Form–36 and 5.5 points lower on the Walking Impairment Questionnaire walking distance domain (p < 0.05 for both). Conclusion: Individuals with a high ABI have higher odds for foot ulcers and neuropathy, as well as lower scores on some physical functioning QoL domains. [Copyright &y& Elsevier]

Background: Tobacco use is an important preventable cause of peripheral artery disease (PAD) and a major determinant of adverse clinical outcomes.Objectives: This study hypothesized that tobacco use by PAD patients would be associated with higher health care utilization and associated costs.Methods: We conducted a retrospective, cross-sectional study using 2011 claims data from the largest Minnesota health plan. The total cohort included individuals with 12 months of continuous enrollment and ≥ 1 PAD-related claim. Tobacco cessation pharmacotherapy billing codes were queried in a subgroup with pharmacy benefits. Outcomes were total costs, annual proportion of members hospitalized, and primary discharge diagnoses.Results: A PAD cohort of 22,203 was identified, comprising 1,995 (9.0%) tobacco users. A subgroup of 9,027 with pharmacy benefits included 1,158 (12.8%) tobacco users. The total cohort experienced 22,220 admissions. The pharmacy benefits subgroup experienced 8,152 admissions. Within 1 year, nearly one-half the PAD tobacco users were hospitalized, 35% higher than nonusers in the total cohort (p < 0.001) and 30% higher in the subgroup (p < 0.001). In both cohorts, users were more frequently admitted for peripheral or visceral atherosclerosis (p < 0.001), acute myocardial infarction (p < 0.001), and coronary heart disease (p < 0.05). Observed costs in the total cohort were $64,041 for tobacco users versus $45,918 for nonusers. Costs for tobacco users also were consistently higher for professional and facility-based care, persisting after adjustment for age, sex, comorbidities, and insurance type.Conclusions: Tobacco use in PAD is associated with substantial increases in PAD-related hospitalizations, coronary heart disease and PAD procedures, and significantly greater costs. The results suggest that immediate provision of tobacco cessation programs may be especially cost effective. [ABSTRACT FROM AUTHOR]

Background: Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known.Objectives: The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC).Methods: Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life.Results: Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC.Conclusions: Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment. [ABSTRACT FROM AUTHOR]

Comparative effectiveness research (CER) aims to provide decision makers with the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart, Lung, and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address 8 clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. [Copyright &y& Elsevier]

Objectives: This study tested the effectiveness of a smoking cessation program designed for patients with peripheral artery disease (PAD). Background: Tobacco use is the leading risk factor for PAD incidence and progression and for ischemic events. Tobacco cessation reduces PAD-related morbidity and mortality, yet few prospective clinical trials have evaluated smoking cessation interventions in PAD patients. Methods: We recruited outpatients with lower extremity PAD identified from medical records as cigarette smokers. Participants were randomly assigned to an intensive tailored PAD-specific counseling intervention or a minimal intervention. Participants completed surveys at baseline and at 3- and 6-month follow-up. Reported 7-day point prevalent smoking abstinence was confirmed by cotinine or carbon monoxide assessment. Results: In all, 687 outpatients were identified as probable smokers with lower extremity PAD; 232 met study eligibility requirements; and 124 (53% of eligible) enrolled. Participants were receptive to counselor contact: the median number of sessions was 8.5 (range 0 to 18). Participants randomly assigned to the intensive intervention group were significantly more likely to be confirmed abstinent at 6-month follow-up: 21.3% versus 6.8% in the minimal intervention group (chi-square = 5.21, p = 0.023). Conclusions: Many long-term smokers with PAD are willing to initiate a serious quit attempt and to engage in an intensive smoking cessation program. Intensive intervention for tobacco dependence is a more effective smoking cessation intervention than minimal care. Studies should be conducted to examine the long-term effectiveness of intensive smoking cessation programs in this population to examine the effect of this intervention on clinical outcomes related to PAD. [ABSTRACT FROM AUTHOR]

Objectives: In the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of ischemic events in patients with intermittent claudication.Background: Previous trials with beraprost sodium, an orally active prostaglandin I(2) analogue, in the treatment of claudication in patients with peripheral arterial disease (PAD) have been inconsistent.Methods: Patients with intermittent claudication (n = 897) were randomized to receive either 40 microg three times a day of beraprost with meals (n = 385) or placebo (n = 377) in a double-blinded manner for one year. The primary efficacy parameter was treadmill-measured maximum walking distance, as assessed at three and six months after randomization. Secondary efficacy parameters included treadmill-measured pain-free walking distance and change in quality of life.Results: There was no significant improvement in maximum walking distance in the beraprost group (16.7%) as compared with the placebo group (14.6%, p = NS). Administration of beraprost did not improve the pain-free walking distance (p = NS between treatment groups), and there was no improvement in the quality-of-life measures between the treatment groups. The incidence of critical cardiovascular events was 7.3% in the beraprost group and 11.4% in the placebo group (p = NS). There was a significant reduction in the combination of cardiovascular death and myocardial infarction in the beraprost group (p = 0.01).Conclusions: Despite previous investigations suggesting efficacy, these results indicate that beraprost is not an effective treatment to improve symptoms of intermittent claudication in patients with PAD. The potential benefit of beraprost on critical cardiovascular events would require confirmation in a larger prospective investigation. [ABSTRACT FROM AUTHOR]

: ObjectivesIn the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of ischemic events in patients with intermittent claudication.: BackgroundPrevious trials with beraprost sodium, an orally active prostaglandin I2 analogue, in the treatment of claudication in patients with peripheral arterial disease (PAD) have been inconsistent.: MethodsPatients with intermittent claudication (n = 897) were randomized to receive either 40 μg three times a day of beraprost with meals (n = 385) or placebo (n = 377) in a double-blinded manner for one year. The primary efficacy parameter was treadmill-measured maximum walking distance, as assessed at three and six months after randomization. Secondary efficacy parameters included treadmill-measured pain-free walking distance and change in quality of life.: ResultsThere was no significant improvement in maximum walking distance in the beraprost group (16.7%) as compared with the placebo group (14.6%, p = NS). Administration of beraprost did not improve the pain-free walking distance (p = NS between treatment groups), and there was no improvement in the quality-of-life measures between the treatment groups. The incidence of critical cardiovascular events was 7.3% in the beraprost group and 11.4% in the placebo group (p = NS). There was a significant reduction in the combination of cardiovascular death and myocardial infarction in the beraprost group (p = 0.01).: ConclusionsDespite previous investigations suggesting efficacy, these results indicate that beraprost is not an effective treatment to improve symptoms of intermittent claudication in patients with PAD. The potential benefit of beraprost on critical cardiovascular events would require confirmation in a larger prospective investigation. [Copyright &y& Elsevier]